FDA 483 - Pharmascience Inc. - February 13, 2024
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An FDA inspection of Pharmascience Inc., a manufacturer of sterile and non-sterile drug products, revealed significant deficiencies in quality control processes. The firm failed to thoroughly investigate out-of-specification results and customer complaints, leading to the release of potentially non-conforming products. Additionally, procedures for preventing microbiological contamination of sterile products were inadequate, and the stability testing program was not followed.
ID · 4a4d1800-cb5b-4bd1-84af-0d0f9f0ad86a